MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number AU00T0

Device Problem Inaccurate Delivery (2339)

Patient Problem Hyphema (1911)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that during an intraocular lens (iol) implantation and planned glaucoma stent procedure, the iol vaulted forward causing a hyphema in the anterior chamber.The surgeon was able to place the iol but not able to complete the planned glaucoma stent procedure due to visibility.The surgeon uses a scleral tunnel approach vs clear cornea approach.Additional information was provided indicating that the iol was extruded from the cartridge with unusual force, rather than delivered slowly.This resulted in the leading edge of the iol striking the iris surface, resulting in hyphema.The procedure was completed.The patient's issues are pending resolution.The surgeon's prognosis is good.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 11595414
• MDR Text Key: 243143542
• Report Number: 1119421-2021-00694
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394789
• UDI-Public: 00380652394789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: AU00T0
• Device Lot Number: 15114194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Outcome(s): Other